Evidence map›Paper›PMID 36652175›Full record

ArticleAdvances in therapy2023

An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations.

Christos Chouaid, Lise Bosquet, Nicolas Girard, Anna Kron, Matthias Scheffler, Frank Griesinger, Martin Sebastian, Jose Trigo, Santiago Viteri, Craig Knott and 16 more

2 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02609776 phase1active not recruitingnot on this map

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorJanssen Research & Development, LLCRan2016 to 2026Enrolled751ConditionsNon-Small-Cell Lung CancerArmsAmivantamab, Lazertinib, Carboplatin, Pemetrexed
NCT03848052 recruitingnot on this map

Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Lung Cancer in France Since 2015

TypeobservationalSponsorUNICANCERRan2017 to 2026Enrolled75,000ConditionsLung Cancer
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 16 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 15 institutions in 6 countries.

Christos ChouaidService de Pneumologie, Pneumology, Intercommunal Hospital, 40 avenue de Verdun, 94010, Créteil, France. christos.chouaid@chicreteil.fr.ORCID http://orcid.org/0000-0002-4290-5524
Lise BosquetHealth Data and Partnerships Department, Unicancer, Paris, France.ORCID http://orcid.org/0000-0001-5100-9425
Nicolas GirardInstitut Curie, Paris, France.ORCID http://orcid.org/0000-0001-9909-2299
Anna KronLung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0002-3047-6486
Matthias SchefflerLung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0002-9031-1368
Frank GriesingerDepartment of Hematology and Oncology, University Department Internal Medicine-Oncology, Pius-Hospital, University Medicine Oldenburg, Oldenburg, Germany.ORCID http://orcid.org/0000-0002-6822-5498
Martin SebastianDepartment of Medicine, Hematology and Oncology, University of Frankfurt, Frankfurt, Germany.ORCID http://orcid.org/0000-0002-0404-7741
Jose TrigoHospital Universitario Virgen de la Victoria y Regional, IBIMA, Malaga, Spain.ORCID http://orcid.org/0000-0002-4489-2683
Santiago ViteriUOMI Cancer Center, Clínica Mi Tres Torres, Barcelona, Spain.ORCID http://orcid.org/0000-0001-8877-4649
Craig KnottHealth Data Insight CIC, Cambridge, UK.ORCID http://orcid.org/0000-0002-8593-6216
Bernardo RodriguesJanssen Cilag, Porto Salvo, Portugal.
Nora RahhaliJanssen Cilag, Île-de-France, France.ORCID http://orcid.org/0000-0002-7989-6035
Jedelyn CabrietoJanssen Pharmaceutica NV, Beerse, Belgium.ORCID http://orcid.org/0000-0001-6413-2000
Joris DielsJanssen Pharmaceutica NV, Beerse, Belgium.ORCID http://orcid.org/0000-0002-9456-9120
Nolen J PerualilaJanssen Pharmaceutica NV, Beerse, Belgium.
Claudio A SchioppaJanssen Pharmaceutica NV, Beerse, Belgium.ORCID http://orcid.org/0000-0002-4148-4676
Jan SermonJanssen Pharmaceutica NV, Beerse, Belgium.
Raphael TouegJanssen Cilag, Île-de-France, France.
Nicole ErdmannJanssen-Cilag GmbH, Neuss, Germany.
Janka MielkeJanssen-Cilag GmbH, Neuss, Germany.
Mehregan Nematian-SamaniJanssen-Cilag GmbH, Neuss, Germany.
Cristina Martin-FernandezJanssen-Cilag Ltd, High Wycombe, UK.
Innocent PfairaJanssen-Cilag Ltd, High Wycombe, UK.
Tracy LiJanssen R&D, Raritan, NJ, USA.
Parthiv MahadeviaJanssen R&D, Raritan, NJ, USA.
Jürgen WolfLung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0002-3869-4736
Janssen (Belgium) · BEJanssen (Germany) · DEJanssen (France) · FRJanssen (United Kingdom) · GBJanssen (United States) · USUniversity of Cologne · DEGoethe University Frankfurt · DEHôpital Intercommunal de Créteil · FRHospital Clínico Universitario Virgen de la Victoria · ESInstitut Curie · FRInstituto Oncológico Dr. Rosell · ESNHS Digital · GBPius Hospital Oldenburg · DEUniCancer Group · FRUniversity Hospital Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with advanced, epidermal growth factor receptor (EGFR)-mutated, non-small cell lung cancer (NSCLC) with Exon 20 insertion mutations (Exon20ins) have poor prognoses, exacerbated by a previous lack of specific treatment guidelines and unmet need for targeted therapies. Amivantamab, an EGFR and MET bispecific antibody, demonstrated efficacy and tolerability in patients with advanced EGFR-mutated NSCLC with Exon20ins following platinum-based therapy in CHRYSALIS (NCT02609776; Cohort D+). Since CHRYSALIS was single-arm, individual patient data (IPD)-based adjusted analyses versus similar patients in real-world clinical practice (RWCP) were conducted to generate comparative evidence.

methodsRWCP cohorts were derived from seven European and US real-world sources, comprising patients fulfilling CHRYSALIS Cohort D+ eligibility criteria. Amivantamab was compared with a basket of RWCP treatments. Differences in prognostic characteristics were adjusted for using inverse probability weighting (IPW; average treatment effect among the treated [ATT]). Balance between cohorts was assessed using standardized mean differences (SMDs). Overall response rate (ORR; investigator- [INV] and independent review committee-assessed [IRC]), overall survival (OS), progression-free survival (PFS; INV and IRC) and time-to-next treatment (TTNT) were compared. Binary and time-to-event endpoints were analyzed using weighted logistic regression and proportional hazards regression, respectively.

resultsPre-adjustment, baseline characteristics were comparable between cohorts. IPW ATT-adjustment improved comparability, giving closely matched characteristics. ORR (INV) was 36.8% for amivantamab versus 17.0% for the adjusted EU + US cohort (response rate ratio [RR]: 2.16). Median OS, PFS (INV) and TTNT were 22.77 versus 12.52 months (hazard ratio [HR]: 0.47; p < 0.0001), 6.93 versus 4.17 months (HR: 0.55; p < 0.0001) and 12.42 versus 5.36 months (HR: 0.44; p < 0.0001) for amivantamab versus the adjusted EU + US cohort, respectively. Results were consistent versus EU- and US-only cohorts, and when using IRC assessment.

conclusionAdjusted comparisons demonstrated significantly improved outcomes for amivantamab versus RWCP, highlighting the value of amivantamab in addressing unmet need in patients with advanced EGFR Exon20ins NSCLC following platinum-based therapy.

trial registrationCHRYSALIS: NCT02609776.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, BispecificErbB ReceptorsHumansMutagenesis, InsertionalMutationProtein Kinase InhibitorsUnited StatesamivantamabAntibodies, BispecificAntineoplastic AgentsErbB ReceptorsProtein Kinase InhibitorsAdjusted comparisonAmivantamabExon 20 insertion mutationsNon-small cell lung cancerReal-world clinical practice

Identifiers

PMID36652175
PMCPMC9988783
OpenAlexW4317213372

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.